This article considers the dilemma that occurs with any discussion regarding method alteration in that it can be open to interpretation.
In the previous articles in this series (Part 1, Part 2, Part 3, Part 4, Part 5, Part 6), we have explored the concept of the adjustment of HPLC methods. In particular, we have tried to determine the difference between method adjustment and method change. The reason for this splitting of hairs is the interpretation of regulatory guidelines that adjustments can be made to meet system suitability requirements, but changes will require some level of revalidation. As a reference point, we used the European Pharmacopoeia (EP) and United States Pharmacopoeia (USP) recommendations. The problem with any discussion of method alteration is that there is a lot of interpretation that goes on.
As a timely way to highlight this dilemma, I received an email recently from a reader, signed “HPLC Chemist at Heart.” She wanted to share her story, but didn’t want to be identified, either individually or corporately. I’ll honor her wishes, but her story is one worth sharing.
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